Plantas medicinais e políticas públicas de saúde: novos olhares sobre antigas práticas / Medicinal plants and public health policies: new perspectives on old practices

Resumo As plantas medicinais são utilizadas nos cuidados a saúde desde a Antiguidade, mas apenas na década de 1970 a OMS se manifestou sobre sua importância para a saúde da população. Este artigo teve por objetivo identificar a sequência temporal e evolução dos marcos legais associados às políticas públicas de plantas medicinais, discutindo as implicações dessa evolução, bem como sua inserção no sistema de saúde, e apresentar essa evolução no Brasil. Foram identificados e analisados os conteúdos de Leis, Decretos, Resoluções, Políticas, Portarias e Instruções Normativas relacionadas ao tema. Apesar do longo histórico de uso da flora nacional, as primeiras legislações sobre seu emprego no campo da saúde são recentes. O Brasil, país com maior biodiversidade do planeta, aprovou, apenas em 2006, a Política Nacional de Práticas Integrativas e Complementares e a Política Nacional de Plantas Medicinais e Fitoterápicos. Necessita-se, entretanto, ampliar o investimento em pesquisas científicas para que haja segurança, qualidade e eficácia no seu uso.

Abstract Medicinal plants have been used in health care since Antiquity, but it was only in the 1970s that the WHO expressed its importance for the health of the population. This article aimed to identify the temporal sequence and evolution of legal frameworks associated with public policies on medicinal plants, discussing the implications of this evolution, as well as its insertion in the health system, and to present this evolution in Brazil. The contents of Laws, Decrees, Resolutions, Policies, Ordinances and Normative Instructions related to the topic were identified and analyzed. Despite the long history of using the national flora, the first legislation on its use in the health field is recent. Only in 2006, Brazil, the country with the greatest biodiversity on the planet, approved the National Policy on Integrative and Complementary Practices and the National Policy on Medicinal Plants and Phytotherapeutics. It is necessary, however, to increase investment in scientific research so that there is safety, quality and effectiveness in its use.

Comprehensive study on the administrative, economic, regional, and regulatory prospects of complementary and alternative medicine (CAM) in inflammatory bowel disease (IBD).

Introduction: Due to the high cost, low effectiveness, and adverse effects plus the life-long nature of inflammatory bowel disease (IBD), and misconception on safety, efficacy, and cost-effectiveness of complementary and alternative medicine (CAM), the market demand for CAM has risen over the past decades. A critical review of patients' and physicians' attitudes, market drivers, economic aspects, regulatory roles, and regional distribution is lacking.Areas covered: Through relevant databases, the existing English language literature concerning the association of CAM use with IBD was collected over the past two decades. Data was then analyzed, comprehensively summarized in tables/figures, and justified concerning administrative, organizational, regional, economic, and regulatory perspectives.Expert opinion: Although CAM utilization is more prevalent among younger, female, and high-educated IBD patients, issues concerning weak study designs, limited-time period/regional distribution of recent surveys, and lack of economic evaluations on CAM make it entirely unfeasible to draw a firm conclusion. Regulators are lagging in meeting the dire need of IBD patients, especially the elderly. Lack of legislation regarding registration, sales monitoring, licensing, insurance coverage, efficacy/safety assessments, post-marketing surveillance, quality assurance, and reference pricing alongside the limited support for CAM research are the main matters that should be urgently addressed.

International policies and challenges on the legalization of traditional medicine/herbal medicines in the fight against COVID-19.

The coronavirus disease 2019 (COVID-19) has now rapidly spread around the world, causing an outbreak of acute infectious pneumonia. To develop effective and safe therapies for the prevention and treatment of COVID-19 has become the major global public health concern. Traditional medicine (TM)/herbal medicines (HMs) have been used to treat multiple epidemics in human history, which brings hope for the fight against COVID-19 in some areas. For example, in China, India, and South Korea with traditional medication history and theory, the governments issued a series of guidelines to support TM/HMs in the medication of COVID-19. In contrast, other countries e.g. North American and European governments are typically silent on these practices, unless to warn of possible harm and overselling. Such difference is due to the discrepancy in culture, history and philosophical views of health care and medication, as well as unharmonized policies and standards in the regulation and legalization of TM/HMs among different areas. Herein, we reviewed the responses and scientific researches from seven selected countries on the policies and legalization of TM/HMs to treat COVID-19, and also analyzed the major challenges and concerns to utilize the traditional knowledge and resource.

"Then I went to a hospital abroad": acknowledging implications of stakeholders' differing risk understandings related to use of complementary and alternative medicine in European health care contexts.

BACKGROUND: Complementary and alternative medicine (CAM) is a rather novel issue within public healthcare and health policy-making. CAM use in Europe is widespread, patient-initiated, and patient-evaluated, and the regulation across countries has been evaluated as disharmonized. CAM users are left in an uncertain position, and patient safety may be threatened. How "risk" is understood by individuals in health policy-making and clinical encounters involving the use of CAM has not yet been much debated. The aim of this article is to explore and discuss the existence and possible consequences of differing risk understandings among stakeholders maneuvering in the complex landscape of CAM practice and CAM regulation contextualized by European public healthcare systems. METHODS: Qualitative data were derived from two studies on CAM in European healthcare contexts. Findings from the EU project CAMbrella on legislation and regulation of CAM were mixed with data from an interview study exploring risk understandings, communication, and decision-making among Scandinavian CAM users and their doctors. In a secondary content analysis, we constructed the case Sara as a typology to demonstrate important findings with regard to risk understandings and patient safety involving European citizens' use of CAM in differing contexts. RESULTS: By combining and comparing individual and structural perspectives on risk and CAM use, we revealed underexplored gaps in risk understandings among individuals involved in European CAM regulation and legislation, and between CAM users and their medical doctors. This may cause health risks and uncertainties associated with CAM use and regulation. It may also negatively influence doctor-CAM user communication and CAM users' trust in and use of public healthcare. CONCLUSION: Acknowledging implications of stakeholders' differing risk understandings related to CAM use and regulation may positively influence patient safety in European healthcare. Definitions of the concept of risk should include the factors uncertainty and subjectivity to grasp the full picture of possible risks associated with the use of CAM. To transform the findings of this study into practical settings, we introduce sets of questions relevant to operationalize the important question "What is risk?" in health policy-making, clinical encounters and risk research involving European patients' use of CAM.

Regulating Alternative Healing in France, And the Problem of 'Non-Medicine'.

This article explores the ambiguities of the legal system that, in France, regulates 'alternative healing', and determines the boundaries of legitimate medical care. While the law suggests that the delivery of therapeutic care should be the monopoly of biomedically-trained professionals, alternative healers operate very widely, and very openly, in France. They practice, however, on the verge of (il)legality, often organising their activities, individually and collectively, so as to limit the likelihood of state intervention. This creates a high degree of precarity for both practitioners and, crucially, for patients. Efforts to change the system are being deployed, but while healers themselves have increasingly organised to seek recognition by the state, alternative healing occupies an uncertain policy space: they are not fully constituted as a social and policy matter by the state, and occupy a liminal position between medicine and spirituality that "unsettles" republican ideals of scientific rationality, and of secularism. This article explores some of those tensions, at the crossroad between law, science, and medicine. It reflects on why tensions seem to persist around the regulatory questions at stake, and suggests that ways forward may depend on moving away from science as a sole arbiter in drawing boundaries of legitimate and illegitimate care in regulation.

Complementary and integrative therapies in the scope of nursing: legal aspects and academic-assistance panorama / Prácticas integradoras y complementarias en el ámbito de la enfermería: aspectos legales y panorama académico-asistencial / Práticas integrativas e complementares no âmbito da enfermagem: aspectos legais e panorama acadêmico-assistencial

ABSTRACT Objective: to carry out a documentary study on the legal aspects that support the nurses' performance in the Integrative and Complementary Practices (PIC) and to discuss the panorama of teaching, research, extension and nursing activities in front of PICs. Method: documentary study, whose units of analysis were normative, guidelines, recommendations and clarification notes (n = 17). The data were organized into two categories: "Legal aspects of nurses' performance in ICP and acupuncture" and "Overview of the use of ICPs by nursing in the areas of teaching, research, extension and assistance activities". Results: nurses stand out in the implementation of PIC since the principles of training are congruent to the paradigms of this science, besides having legal support for acting in public and private services in Brazil. There is an incipient movement of nurses working in research and extension in universities, which contributes to the diffusion of knowledge and application of therapies in the community. Conclusion: the institutionalization of PICs in the Unified Health System has increased access and contributed to the provision of comprehensive and multidisciplinary health services. Implications for practice: with ICPs, nurses have achieved autonomy and the possibility of expanding their performance, aiming at a better quality of care.

RESUMEN Objetivo: realizar un estudio documental sobre los aspectos legales que respaldan la actuación del enfermero en las Prácticas Integradoras y Complementarias (PIC) y discurrir sobre el panorama de la enseñanza, investigación, las actividades extensionistas y asistenciales de la Enfermería frente a las PIC. Método: estudio documental, cuyas unidades de análisis fueron normativas, directrices, recomendaciones y notas de aclaración (n = 17). Se organizaron los datos en dos categorías: "Aspectos legales de la actuación del Enfermero en las PIC y en la acupuntura" y "Panorama de la utilización de las PIC por la enfermería en las áreas de enseñanza, investigación, actividades extensionistas y asistenciales". Resultados: los enfermeros se destacan en la implementación de las PIC, ya que los principios de formación son congruentes a los paradigmas de esta ciencia, además de poseer respaldo legal para actuación en servicios públicos y privados en Brasil. Hay un movimiento incipiente de enfermeros actuando en investigaciones y extensión en las universidades, lo que contribuye a la difusión del conocimiento e implementación de terapias en la comunidad. Conclusión: la institucionalización de las PIC en el Sistema Único de Salud amplió el acceso y contribuye a una disponibilidad de servicios de salud integral y multidisciplinar. Implicaciones para la práctica: con las PIC los enfermeros han alcanzado autonomía y la posibilidad de expandir su actuación, con vistas a una mejor calidad del cuidado.

RESUMO Objetivo: Realizar estudo documental sobre os aspectos legais que respaldam a atuação do enfermeiro nas Práticas Integrativas e Complementares (PIC) e discorrer sobre o panorama do ensino, pesquisa, atividades extensionistas e assistenciais da Enfermagem frente às PIC. Método: Estudo documental, cujas unidades de análise foram normativas, diretrizes, recomendações e notas de esclarecimento (n=17). Os dados foram organizados em duas categorias: "Aspectos legais da atuação do Enfermeiro nas PIC e na acupuntura" e "Panorama da utilização das PIC pela enfermagem nas áreas de ensino, pesquisa, atividades extensionistas e assistenciais". Resultados: Os enfermeiros se destacam na implementação das PIC uma vez que os princípios de formação são congruentes aos paradigmas dessa ciência, além de possuírem respaldo legal para atuação em serviços públicos e privados no Brasil. Há um movimento incipiente de enfermeiros atuando em pesquisas e extensão nas universidades, o que contribui para difusão do conhecimento e aplicação das terapias na comunidade. Conclusão: A institucionalização das PIC no Sistema Único de Saúde ampliou o acesso e tem contribuído para disponibilização de serviços de saúde integral e multidisciplinares. Implicações para prática: Com as PIC os enfermeiros têm alcançado autonomia e possibilidade de expansão de sua atuação, com vistas à melhor qualidade do cuidado.

Statutory Regulation of Traditional Medicine Practitioners and Practices: The Need for Distinct Policy Making Guidelines.

The World Health Organization (WHO) has called for the increased statutory regulation of traditional and complementary medicine practitioners and practices, currently implemented in about half of nations surveyed. According to recent WHO data, however, the absence of policy guidelines in this area represents a significant barrier to implementation of such professional regulations. This commentary reviews several key challenges that distinguish the statutory regulation of traditional medicine practitioners and practices from biomedical professional regulation, providing a foundation for the development of policy making parameters in this area. Foremost in this regard are the ongoing impacts of the European colonial encounter, which reinforce biomedicine's disproportionate political dominance across the globe despite traditional medicine's ongoing widespread use (particularly in the global South). In this light, the authors discuss the conceptual and historical underpinnings of contemporary professional regulatory structures, the tensions between institutional and informal traditional medicine training pathways, and the policy challenges presented by the prospect of standardizing internally diverse indigenous healing approaches. Epistemic and evidentiary tensions, as well as the policy complexities surrounding the intersection of cultural and clinical considerations, present additional challenges to regulators. Conceptualizing professional regulation as an intellectual property claim under the law, the authors further consider what it means to protect traditional knowledge and prevent misappropriation in this context. Overall, the authors propose that innovative professional regulatory approaches are needed in this area to address safety, quality of care, and accessibility as key public interest concerns, while prioritizing the redress of historical inequities, protection of diverse indigenous knowledges, and delivery of care to underserved populations.

Pediatric Integrative Medicine.

The American Academy of Pediatrics is dedicated to optimizing the well-being of children and advancing family-centered health care. Related to this mission, the American Academy of Pediatrics recognizes the increasing use of complementary and integrative therapies for children and the subsequent need to provide reliable information and high-quality clinical resources to support pediatricians. This Clinical Report serves as an update to the original 2008 statement on complementary medicine. The range of complementary therapies is both extensive and diverse. Therefore, in-depth discussion of each therapy or product is beyond the scope of this report. Instead, our intentions are to define terms; describe epidemiology of use; outline common types of complementary therapies; review medicolegal, ethical, and research implications; review education and training for select providers of complementary therapies; provide educational resources; and suggest communication strategies for discussing complementary therapies with patients and families.

Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch.

US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA-approved companion or complementary diagnostic status.

CAM within a field force of countervailing powers: The case of Portugal.

This paper examines the extent to which the position of the medical profession and the state towards complementary and alternative medicine (CAM) practitioners has changed since the late 1990s, taking Portugal as a case study. Using Light's concept of countervailing powers, we consider the alliances, interests, rhetoric and degrees of control between these three actors over time, focussing particularly on the extent to which CAM practitioners have acted as a countervailing force in their relationship with the medical profession and the state. It also brings to the fore the position of supra-state agencies concerning CAM regulation. A critical discourse analysis was conducted on data derived from a systematic search of information dating from the late 1990s up to 2015. Our analysis suggests that CAM has emerged as an active player and a countervailing power in that it has had significant influence on the process of state policy-making. The medical profession, in turn, has moved from rejecting to 'incorporating' CAM, while the state has acted as a 'broker', trying to accommodate the demands and preferences of both actors while simultaneously demonstrating its power and autonomy in shaping health policy. In sum, the history of countermoves of CAM, the medical profession and the state in recasting power relations regarding CAM regulation in Portugal has highlighted the explanatory value of Light's countervailing power theory and the need to move away from a professional dominance and corporatist approach, in which CAM has simply been seen as subjugated to the power of the medical profession and the state.

Molecular mechanisms of pharmacological doses of ascorbate on cancer cells.

Intravenous application of high-dose ascorbate (vitamin C) has been used in complementary medicine since the 1970s to treat cancer patients. In recent years it became evident that high-dose ascorbate in the millimolar range bears selective cytotoxic effects on cancer cells in vitro and in vivo. This anticancer effect is dose dependent, catalyzed by serum components and mediated by reactive oxygen species and ascorbyl radicals, making ascorbate a pro-oxidative pro-drug that catalyzes hydrogen peroxide production in tissues instead of acting as a radical scavenger. It further depends on HIF-1 signaling and oxygen pressure, and shows a strong epigenetic signature (alteration of DNA-methylation and induction of tumor-suppressing microRNAs in cancer cells). The detailed understanding of ascorbate-induced antiproliferative molecular mechanisms warrants in-depth preclinical evaluation in cancer-bearing animal models for the optimization of an efficacious therapy regimen (e.g., combination with hyperbaric oxygen or O2-sensitizers) that subsequently need to be evaluated in clinical trials.

Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues.

Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have recently been found unconstitutional under the First Amendment, which has been interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform consumers' health choices. A few small studies reported a modest impact of disclaimers on consumers' attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs, and it risks returning the United States to a previous era when inappropriate marketing claims about prescription drugs proliferated and contributed to the inappropriate use of those products.

Política Estadual de Práticas Integrativas e Complementares-PEPIC/RS / State Policy of Integrative and Complementary Practices-PEPIC / RS

A instituição da Política Nacional de Práticas Integrativas e Complementares (PNPIC), (BRASIL, 2006) veio responder às reivindicações por essas práticas já há muito colocadas pela população em favor de mudanças nos modelos de atenção instituídos. A PNPIC se soma à Política Nacional de Humanização (PNH) (BRASIL, 2004), à ampliação do direito dos usuários em relação à opções terapêuticas estabelecidas, quando propõe a inserção de práticas com abordagens baseadas na integralidade, complementares às práticas já estabelecidas. A PNPIC promoveu a reflexão sobre essas possibilidades e definiu funções para as instâncias estaduais de gestão do Sistema Único de Saúde (SUS) na sua implementação.

The role of civil society organizations in the institutionalization of indigenous medicine in Bolivia.

December 2013 marked a significant shift in Bolivia with the enactment of a law for the inclusion of indigenous doctors in the National Health System. This article traces the constellation of forces that led to the institutionalization of indigenous medicine in Bolivia. It identifies three factors contributing to this health policy change. The first factor is the crystallization of a strong indigenous movement fighting for the recognition of cultural rights through the foundation of civil society organizations. Second is the rise to power of Evo Morales, the first Latin American president of indigenous origin, who has promoted multicultural policies, formally supported through the promulgation of a new constitution. Lastly is the influence of the global acceptance of alternative medicine. Indigenous doctor organizations in Bolivia have been highly involved throughout the entire process of institutionalization and have played a crucial role in it. An analysis of the relationship between these civil society organizations and the Bolivian government reveals a strong partnership. This dynamic can be described in terms of Interdependence Theory, as each party relied on the other in the promotion and practice of the law to achieve the integration of indigenous medicine as part of the Bolivian Health System.